NCT05961852已完成1 期
COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Target lesion primary patency
研究概览
简要总结
To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.
详细描述
This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having > 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.
The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failing mature upper limb AVF
- •Resistant stenosis (>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
- •Patient is >= 21 years of age
- •Ability to provide informed consent
排除标准
- •Thrombosed AVF
- •Target lesion has a sharp angle (> 45 degrees)
- •Lesions requiring cutting balloon size > 7 mm
- •Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
- •Contraindication to dual antiplatelet therapy
- •Severe allergy to contrast media that cannot be adequately managed for the procedure
- •Breast-feeding and/or pregnant females
- •Male patients who are planning to father children during the trial period
- •Unable to comply with follow up protocol (for instance, limited life expectancy)
结局指标
主要结局
Target lesion primary patency
时间窗: 6 months after index procedure
Time from index treatment to repeat treatment of target lesion or thrombosis of circuit.
次要结局
未报告次要终点
研究者
研究点 (2)
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